Revascularization in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) With Multivessel and/or Unprotected Left Main Coronary Disease (MILESTONE)
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Purpose
MILESTONE STUDY is dedicated to problems connected with patients with multivessel coronary artery disease and/or with left main narrowing who present symptoms of acute ischemia. For such kind of patients according to current ACC/AHA guidelines CABG (surgical revascularization) is recommended as a treatment method. In comparison with CABG, recent studies have shown that PCI (percutaneous coronary intervention) is associated with a lower rate of periprocedural adverse events and similar long term event-free survival in patients with left main disease. Our latest non randomized registry and randomized LEMANS study, comparing LMCA (left main coronary artery) stenting with CABG confirmed above findings. LEMANS ACS (acute coronary syndrome) retrospective registry of patients with UPLMCA (unprotected LMCA) disease and non ST elevation ACS showed lower 30 day and trend toward lower one year mortality after PCI when compared with CABG. It should be stressed, that acute ischemia substantially increase the risk of CABG. In fact, there are limited data on the outcome of ULMCA stenting or CABG in patients with acute coronary syndromes (ACS).
Similarly, all randomized studies comparing PCI vs CABG in multivessel disease included mainly patients with stable angina, small cohort of patients with unstable angina and they excluded patients with non ST elevation Myocardial infarction.
In the SYNTAX study -largest PCI vs CABG trial, randomized patients were patients with low perioperative risk (logistic EUROSCORE <5) and ACS patients routinely excluded. High perioperative risk patients were included only in PCI registry.
| Condition | Intervention |
|---|---|
|
Multi Vessel Coronary Artery Disease Acute Coronary Syndrome |
Procedure: PCI Procedure: CABG |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Revascularization Strategy (PCI With DES Implantation vs CABG) in Patients With Non ST Elevation Acute Coronary Syndrome With Multivessel and/or Unprotected Left Main Coronary Disease |
- All cause death [ Time Frame: One year after revascularization procedure ] [ Designated as safety issue: No ]The primary endpoint is a composite of all death one year after revascularization procedure: PCI or CABG. The hypothesis test is designed to show non-inferiority of PCI to CABG for the primary endpoint
- Composite of MACCE [ Time Frame: peri-hospital period, one month and one year after revascularization procedure ] [ Designated as safety issue: No ]MACCE is defined as: all death, myocardial infarction, stroke, or unplanned revascularization
- Procedural and post procedural complication [ Time Frame: peri-hospital period, one month and one year after revascularization procedure ] [ Designated as safety issue: No ]Procedural and post procedural complication: length of hospital stay and frequency of prolonged hospitalization ; return to work; readmissions and cause of readmissions; angina and functional status; medications.
- Overall costs of treatment strategies. [ Time Frame: one year ofter revascularization procedure ] [ Designated as safety issue: No ]Hospital costs and long-term cost-effectiveness.
- Occurence of stent thrombosis or graft occlusion [ Time Frame: peri-hospital period, one month and one year after revascularization procedure ] [ Designated as safety issue: No ]Stent trombosis will be defined in accordance with ARC definition.
- Hemorrhagic complications. [ Time Frame: peri-hospital period, one month and one year after revascularization procedure ] [ Designated as safety issue: No ]Hemorrhagic complications will be clasified according to TIMI scale.
- Frequency and impact of complete revascularization [ Time Frame: one year after revascularization procedure ] [ Designated as safety issue: No ]Complete revascularization will be defined on an anatomic basis and by revascularization of all significant ischemic areas.
| Estimated Enrollment: | 1000 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PCI with DES implantation
Percutaneous Coronary Intervention Implantation of Drug-Eluting Stents
|
Procedure: PCI
Percutaneous Coronary Intervention
Other Names:
|
|
Active Comparator: CABG
Coronary Artery Bypass Grafting.On-pump or Off-pump CABG
|
Procedure: CABG
Coronary Artery Bypass Graft
Other Names:
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Acute Coronary Syndrome without ST elevation (NSTE-ACS): Unstable Angina (Braunwald's class IB,IC,IIB,IIC,IIIB,IIIC) or Non ST Elevation Myocardial Infarction (NSTEMI)
- Two vessel disease with proximal LAD stenosis or three vessel disease
- Unprotected Left Main Coronary Artery (ULMCA) de novo disease with or without concomitant single or multivessel coronary artery disease
- Patient eligible both for CABG and PCI, confirmed by interventional cardiologist and surgeon offering similar extension of revascularisation
- Signed informed consent
Exclusion Criteria:
- age <21
- ST Elevation Myocardial Infarction;
- Stable angina;
- Patients in Killip IV class;
- Patients required immediate PCI procedure (e.g. electric instability);
- Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 1 year
- History of haemorrhagic stroke
- Ischemic stroke or TIA within past 6 weeks.
- Hematocrit <30%
- Platelet Count <100.000/mm3
- Chronic renal insufficiency with creatinine clearance<30 ml/min/1,73m2,
- Concomitant structural or valve disease requiring cardiac surgery
- Prior PCI of left main trunk at any time prior to randomization
- Prior PCI of any other coronary artery lesion within 1 year prior to randomization
- Prior CABG at any time prior to randomization
- Need for any concomitant cardiac surgery other than CABG (e.g. valve surgery, aortic repair, etc.), or intent that if the patient will be randomized to surgery, any cardiac surgical procedure other than isolated CABG will be performed
- Patients requiring additional surgery (cardiac or non cardiac) within 1 year
- Pregnancy or intention to become pregnant (women of child bearing age must have a recent negative pregnancy test prior to randomization)
- Non cardiac co-morbidities with life expectancy less than 3 years
Contacts and Locations| Contact: Iwona Banasiewicz-Szkrobka, MD,PhD | 0048602457602 | wilenka@wp.pl |
| Contact: Stanislaw Trznadel, MD | strznadel@vp.pl |
| Poland | |
| American Heart of Poland, Malopolska Centre for Heart and Vascular Disease | Not yet recruiting |
| Chrzanow, Malopolska, Poland, 32-500 | |
| Contact: Iwona Banasiewicz-Szkrobka, MD, PhD 0048602457602 wilenka@wp.pl | |
| Principal Investigator: Iwona Banasiewicz-Szkrobka, MD, PhD | |
| Sub-Investigator: Aleksander Zurakowski, MD,PhD | |
| American Heart of Poland, 2-nd Department of Cardiology | Not yet recruiting |
| Bielsko-Biala, Silesia, Poland, 43-316 | |
| Contact: Bogdan Gorycki, MD,PhD (+48) (33) 829 08 63; (33) 810 | |
| Principal Investigator: Bogdan Gorycki, MD,PhD | |
| American Heart of Poland,3-rd Depatment of Invasive Cardiology, Angiology and Electrophysiology | Not yet recruiting |
| Dabrowa Gornicza, Silesia, Poland, 41-300 | |
| Contact: Marek Kondys, MD,PhD (+48) (33) 829 08 63; (33) 810 | |
| Principal Investigator: Marek Kondys, MD,PhD | |
| Sub-Investigator: Marcin Debinski, MD,PhD | |
| American Heart of Poland 1-st Department of Cardiology and Angiology | Not yet recruiting |
| Ustron, Silesia, Poland, 43-450 | |
| Contact: Marek Krol, MD,PhD (+48) (33) 854 58 57, (33) 854 m.krol@klinikiserca.pl | |
| Principal Investigator: Marek Krol, MD,PhD | |
| Silesian Centre for Heart Disease, Department of Cardiosurgery and Transplantation | Not yet recruiting |
| Zabrze, Silesia, Poland, 41-800 | |
| Contact: Mariusz Gasior, Prof 004832 273 26 81 | |
| Principal Investigator: Marian Zembala, Prof. | |
| Principal Investigator: Mariusz Gasior, Prof | |
| Principal Investigator: | Pawel E Buszman, Prof | American Heart of Poland |
| Study Director: | Stanislaw Trznadel, MD | American Heart of Poland |
More Information
Publications:
| Responsible Party: | Professor Pawel E. Buszman, MD, PhD, FESC, FACC, FSCAI,, American Heart of Poland |
| ClinicalTrials.gov Identifier: | NCT01311323 History of Changes |
| Other Study ID Numbers: | AHP-1 |
| Study First Received: | March 8, 2011 |
| Last Updated: | March 8, 2011 |
| Health Authority: | Poland: Ethics Committee |
Keywords provided by American Heart of Poland:
|
Multivessel Coronary Artery Disease Left Main Narrowing Percutaneous Coronary Intervention Coronary Artery Bypass Grafting Drug-Eluting Stent |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Acute Coronary Syndrome Heart Diseases Cardiovascular Diseases Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Angina Pectoris Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013